Speaker announcement: Sofia Segersson from Diabetesia
Medical Device Product Life Cycle – a conference for QA & RA professionals! We are happy to welcome the next speaker to our Medical Device Product Life Cycle – QA/RA conference on the 26-27th of October in Lund: Sofia Segersson, Owner, Consultant, Entrepeneur at Diabetesia.se Sofia will speak about a very interesting topic “Medical Devices as Part of […]
Speaker announcement: Judith de Wilde from Axon Lawyers
Make compliance your success factor – a conference for QA/RA professionals We are delighted to welcome the next speaker to our Medical Device Product Life Cycle – QA/RA conference on the 26-27th of October in Lund: Judith de Wilde, Attorney at Law at Axon Lawyers Judith will deliver two presentations at the conference: Interaction between manufacturers […]
First speaker announced – Medical Device Product Life Cycle Conference
Make compliance your success factor – a conference for QA/RA professionals We are delighted to introduce the first speaker Cyrille Michaud at our upcoming conference on the 26-27th of Ocotober in Lund, Sweden. The title of Cyrille’s presentation is “Device Software and Change control – how can SW manufacturers manage changes under MDR?” Short introduction […]
Vitalis 2022 – Join our presentation on the 17th of May
Are you a manufacturer of a medical device software and curious to know more about clinical evaluation? Then you should visit Scandinavia’s largest eHealth event, Vitalis 2022, next week and listen to Johanna Fugelstad presentation. She will talk about clinical evaluations and highlight some basic and important concepts of the process. Date: 17th of May Time: […]
MVA Boost Seminar – From idea to success
– Join our Boost Seminar together with Medicon Valley Alliance in Copenhagen There are a large number of new start-ups in Medical Device and In Vitro Diagnostics in the Medicon Valley area. This seminar will focus on how a start-up in Medical Device or In Vitro Diagnostic can accelerate the development from idea to success […]
Free webinar: Application for Clinical Investigations
How to prepare your submission package Learn from our experienced clinical development consultants which documents are required, what to consider and how to avoid delays. In this session, you will an overview on the documents and process required. It is teaser for the upcoming Key2Compliance training/course on Medical Device Clinical Investigations in May. Which documents […]
Free webinar: Is your medical device software MDR ready?
There are lots of great ideas and products related to medical device software today. Many of them already are compliant to the Medical Devices Directive (MDD), others are in an earlier development state. Since May 26th, 2021, the Medical Devices Regulation (MDR) is in force and latest May 26th, 2024, all medical device software has […]
Thank you for attending the Biological and Clinical Evaluations Conference for Medical Devices
Thank you to all our delegates, speakers, moderators, and exhibitors for making the Biological and Clinical Evaluations Conference for Medical Devices such a positive, interesting, inspiring, exciting, and fun two days! It was wonderful to meet you all in Malmö! We hope to see you next year!
FREE Webinar – An overview of IEC 62304 Medical Device software
Join us for this free webinar January 25, 2021 • 14.00-14.20 CET Learn more about how you can comply with the IEC 62304 standard in your Medical Device software development and maintenance process. When to apply IEC 62304? Overall development process for a medical device that is or includes Software Main points of IEC 62304 […]
Free BSI Webinar – UKCA for Medical devices and IVDs, are you ready?
Free live webinar Join BSI’s Dr Jayanth Katta, Head of UK Approved Body, Regulatory Services, to hear the latest updates on Brexit and the new UK Conformity Assessed mark (UKCA) for medical devices. More information: https://www.bsigroup.com/en-GB/medical-devices/brexit-medical-devices/ Register: Tuesday, 12 January, 2021 9:00 – 10:00 GMT Tuesday, 12 January, 2021 16:00 – 17:00 GMT